Investigator Essentials

The IBC oversight applies to all activities involving biohazardous materials at or supported by the UMassD regardless of funding.

The biohazardous materials which the IBC currently oversees include:

1. Large-scale cultures and whole organisms:
   • Large-scale cultures or volumes exceeding 10 liters of culture.
   • Whole animals or whole plants, including transgenic varieties.
   • Organisms, which if released, could have a significant impact on the environment (i.e., exotic plants, non-indigenous plant pathogens or regulated insects) or are export controlled.
2. Biohazardous materials and biological samples:
   • Biohazardous materials, nanomaterials, biological agents (infectious, parasitic, pathogenic, or of unknown pathogenicity), or genetically engineered/modified microorganisms (bacteria, viruses, fungi, protozoa, yeast, algae, etc.); including: storage or concentration of any materials which pose zoonotic disease concerns.
   • Biological specimens (blood or blood components, cellular lines/materials, tissues, feces, saliva, urine, or byproduct) known or suspected to be contaminated with an infectious or biohazardous agent.
   • Biological toxins, synthesized toxins, bioactive derivatives, or subunits of toxins andFederal Select Agents and Toxins.
3. Genetic manipulation and host-vector systems:
   • Nucleic acid molecules (DNA, synthetic DNA [sDNA], recombinant DNA [rDNA], RNA, or synthetic RNA [sRNA]) and prions or prion-like proteins.
   • Manipulation of genetic material via cloning, editing, synthesis, transformation, recombination, or mutagenesis.
   • Host-vector systems, including non-pathogenic prokaryotes or lower eukaryotic hosts, employing Risk Group 2, 3, 4, or other restricted agents.
   • Xenotransplantation or transfer of genetic material into humans, whole animals, or plants, or microorganisms.
4. Other:
   • Soil seed, spores, plant pathogens (bacteria, viruses, fungi, or parasite), or any other material received under an agreement or permit.
   • Necropsy of animals not under the care of the University Veterinarian, necropsy of animals with unknown health status and/or animals reasonably suspected or known to be infectious.
   • Except for general surveillance, arthropods that serve as vectors of disease to humans, animals, or plants and arthropods considered an environmental hazard.
   • Studies which pose a Dual Use Research of Concern.
   • Export controlled biological agents and biopharmaceuticals.
   • Other work as deemed necessary for review by the Biological Safety Officer, IBC, or sponsor.

From this point forward, the term "biohazardous materials" refers to the agents and substances listed above.

For more information, email ibc.research@umassd.edu.

 

Part B – Classification and Confirmations

Part C – Material Information

Biohazardous Material(s): Identify the biohazardous material(s) being used, specify the corresponding biosafety level (BSL) and risk group (RG), and provide product safety sheets (SDS) to confirm the assigned BSL and risk group for the materials being used.

Source of Material:  Identify the source of the materials and any associated agreements (e.g., Material Transfer Agreements).

Material Characteristics: Describe any unique characteristics of the materials (e.g., cell lines, vectors, phages, genes) and indicate whether these characteristics impact the assigned biosafety level.

Publication Support: Provide relevant publications for reference that support the proposed research and use of the biohazardous materials.

Part D – Protocol Information

Host and Vector Information [Attach corresponding detailed vector maps that illustrate the constructs being utilized]

• Identify the bacteria (e.g., E. coli K12) and/or mammalian cell lines (e.g., HeLa cells) that will serve as hosts for the recombinant DNA.
• Specify the cells used for amplification of recombinant DNA and their source.

Background, Study Design, & Intended Use of Material(s)

• Clearly articulate the overarching goal of the research and outline the central research question being addressed.
• Explain the significance of the study and the reasons for using the proposed biohazardous materials.
• Describe the methodology in lay terms, include a flowchart or schematic diagram illustrating the experimental design if necessary.
• Specify any control groups included to validate results.
• Assess any potential environmental impacts associated with the use of biohazardous materials.
• Outline how the research will be monitored for safety and provide a detailed emergency response plan for accidents or exposures.
• Mention any collaborations or external support related to the study.
• Discuss any long-term plans for monitoring or follow-up studies.

Material and Methods

• If using recombinant DNA molecules or manipulations, provide vector maps as necessary. Include details about the recombinant DNA constructs, such as: the origin of the vector, key features (promoters, resistance genes, etc.), and any modifications made to the vector.
• Outline procedures and techniques to be performed (e.g., cloning, DNA or RNA synthesis, expression, cell culture, etc.).
• Include any recombinant DNA gene manipulations/gene editing, identifying the gene product (protein) you wish to express.
• If using viruses, identify the viral vector(s), marker genes, and foreign insert genes. Clarify replication features and whether they are replication-deficient or replication-competent.

Risks

• Assess potential risks associated with the use of and exposure to biohazardous materials.
• Address the potential for accidental exposure and specify how such exposure might occur.
• Explain potential repercussions of human exposure and available treatment options.
• For studies using a BSL2 agent, provide a separate Biological Hazards Material Standard Operating Protocols (BHMSOP).

Management of Biohazards

• Describe the equipment and locations where biohazardous materials will be handled.
• Outline the training the PI will implement to protect staff from hazards.
• Detail the response plan for handling accidental exposures.
• Describe biosecurity measures in place to minimize access to the lab facility.
• Describe methods for storage, transport, decontamination, and disposal of biohazardous materials.

Part E - Appendices

Appendix for Animal Use [Attach required IACUC Approval]

Identification of Animal Models:

• Provide details about the animal models being used, including species and source.
• Specify the type of materials involved in the study and the biosafety level required for the animal models used.
• Clarify whether the agent occurs naturally in the species being used.
• State the number of experimental animals to be used and number of experiments to be conducted in the study.
• Clarify whether any cells will be purposely infected with human or animal pathogens?
• Describe procedures to minimize risks during the infection process, including:
  • Use of appropriate personal protective equipment (PPE) such as gloves, gowns, masks, and face shields.
  • Implementation of biosafety cabinets or containment facilities during inoculation.
  • Training for staff on handling biohazardous materials and emergency response protocols.
• Describe how materials will be handled to minimize the risks of accidental exposure to pathogens. Include:
  • Testing for pathogen-free status; if not tested, specify the need for bloodborne pathogen screening.
  • Procedures for managing any accidental exposures or spills.
• Outline how staff and occupants will be informed about infection procedures and associated risks:
  • Regular safety briefings and training sessions.
  • Posting clear signage indicating areas of biohazard risk and access restrictions.
  • Providing written protocols and contact information for the biosafety officer or designated safety personnel.
• Provide estimates of when after inoculation the animal may begin shedding the agent, typically ranging from a few days to weeks.
  • Discuss potential hazards to human health associated with shedding: routes of transmission (e.g., aerosol, direct contact).
  • Symptoms to monitor in staff who may encounter infected animals
  • Containment measures to be enacted during the shedding period.

Appendix for Human Subject Use [Attach required IRB Approval]

• Identify the source of human materials used in the study (e.g., whole human, cell lines, body fluids).
• Specify the type of human materials involved in the study.
• Clarify if any known pathogens exist in the materials and how they will be disposed of.
• Clarify if human cells will be purposely infected with human pathogens. 
• Describe precautions to minimize risks associated with infection.

Appendix for Select Agent Use

• Identify each agent being used, including the source and biosafety level (BSL).
• Provide relevant permit numbers and dates obtained for the select agents.
• Clarify storage conditions and security measures in place for the select agents.
• Outline plans for notification in case of accidental exposure.

Appendix for Toxin Use

• Identify the toxin being used, including the source and biosafety level (BSL).
• Specify the LD50 for the toxin.
• Identify symptoms associated with exposure to the toxin.
• Clarify how personnel will be monitored post-handling of the toxin.
• Outline the procedures to be used for inactivating the toxin, including:
  • Specific methods (e.g., chemical agents, heat treatment, enzymatic degradation).
  • Duration and conditions (temperature, pH, etc.) necessary for effective inactivation.
• Describe in detail the methods used to verify the efficacy of inactivation, including:
  • Analytical techniques (e.g., bioassays, toxicity assays) to confirm the absence of active toxin.
  • Environmental monitoring procedures to assess any residual toxicity in the work area.
  • Record-keeping practices to document inactivation results and any corrective actions taken if inactivation fails.

For new submissions, include:

• Reference Publications: Scholarly articles or studies that support the proposed research and use of biohazardous materials.
• Product Safety Sheets: Safety data sheets (SDS) that provide information on the properties, hazards, and safe handling practices for the biohazardous materials used.
• Training Records: Documentation of completed training sessions for all personnel involved in handling biohazardous materials, including dates and topics covered.

Include the following as applicable:

• Grant Awards: Documentation of funding sources that support the research project, including grant numbers and details about the funding organization.
• Material Transfer Agreements: Legal documents outlining the terms and conditions for transferring biohazardous materials between institutions or parties.
• End User Agreements: Contracts that specify the responsibilities of the end user regarding the handling and use of biohazardous materials.
• Vector Maps: Diagrams detailing the genetic constructs used in the research, including information about the origin of the vector and key features.
• IACUC Approval Documents: Approval letters or protocols from the Institutional Animal Care and Use Committee, confirming compliance with animal research regulations.
• IRB Approval Documents: Approval letters or protocols from the Institutional Review Board, confirming compliance with regulations for research involving human subjects.
• Biosafety Permits: Regulatory approvals necessary for the use of certain biohazardous materials, including permits for select agents or toxins.

For all revisions, include as appropriate:

• Revised Protocols: Updated research protocols or standard operating procedures reflecting any changes made in response to the incident should be provided. Relevant documentation relating to the revision of study design or changes in materials used (reference publications, vector maps, MSDS, etc.) must be included.
• Training Records: Evidence of additional training provided to personnel following the incident, ensuring understanding of new procedures or safety measures, should be documented.

To meet the criteria for approval, the Institutional Biosafety Committee (IBC) must ensure the following conditions are satisfied:

1. Appropriate Expertise: The IBC members and any external consultants involved in the review must have the necessary expertise to understand and evaluate the scientific, biosafety, and ethical aspects of the research. This includes, but is not limited to, knowledge in characteristics of biological agents (e.g., virulence, pathogenicity, environmental stability), genetic manipulations involved in the study, source, nature, and function of inserted genetic material, host/vector systems, biosafety containment measures appropriate for the risk group, occupational health and environmental safety concerns, NIH Guidelines, relevant biosafety protocols, and containment methodologies for animals and plants. If the IBC lacks the necessary expertise for a specific protocol, it may seek input from external experts, ensuring there is no conflict of interest.
2. Appropriate Biosafety Containment and Risk Assessment: The containment level for the research must be appropriate for the risk group of the study agents. A thorough risk assessment must be conducted to ensure that risks to personnel, co-occupants, and the public environment are reasonable, including consideration of the nature of the study agent, the risk group, and any genetic modifications introduced. Risk to personnel, students or visitors, and environment is reasonable in relation to the threats and hazards associated with use of the materials.
3. Effective Safety Procedures: Safety procedures are developed and monitored for hazards and risks associated with the project or activity. Safety procedures must be developed in collaboration with Environmental Health and Safety (EHS) staff and the BSO to address associated hazards and risks. The BSO is available to assist Principal Investigators (PIs) in the development of individual BioHazardous Material Standard Operating Procedures (BHMSOPs) tailored to each study and lab. Risks to personnel, students, or visitors must be reasonable compared to the threats posed by the materials. Additionally, risks to community health and the environment must be adequately mitigated, and necessary medical measures, such as occupational health consultations, must be in place to minimize risks. EHS staff may conduct routine monitoring of facilities to ensure compliance. Where appropriate, preventative medical measures are taken to minimize risks associated with breeches in safety procedures (including any required occupational health consultations).
4. Adequate Emergency Response Plans and Facilities: Adequate emergency plans must be in place to handle accidental spills, exposures, or other unforeseen incidents, including protocols for responding to researcher or personnel contamination. The research facilities and operational procedures are sufficient to protect against the risks posed by the research, including proper use of containment equipment, safety protocols, and regular safety training programs.
5. Compliance with Guidelines: The proposed research must comply with the NIH Guidelines, the Biosafety in Microbiological and Biomedical Laboratories (BMBL) manual, and any other applicable institutional or federal biosafety regulations.
6. Completion and Consistency of Registration Materials: All registration documents must be complete, consistent, and compliant with the NIH Guidelines, the BMBL, and the IBC’s Charter. Incomplete or inconsistent applications may result in the delay or denial of approval. All necessary documents have been provided with review (reference publications, Material Data Safety Sheets, vector maps, training certificates, and external agreements and permits, etc).
7. Proper Assessment and Monitoring of Risks and Noncompliance: Any previous instances of unanticipated risks, noncompliance, or new information must be considered during the review process. Ongoing monitoring of the research process must be conducted to identify any emerging risks or issues, with clear requirements for reporting to the IBC. If required, modifications to protocols, corrective action plans, or enhanced monitoring may be mandated.

These criteria ensure that the research is conducted safely, ethically, and in compliance with all relevant regulations, while also addressing potential gaps in expertise and preparedness.

CITI Online Training Requirement

All personnel involved in the use of biohazardous materials in research activities or in the academic laboratory training of students are required to complete the online Collaborative Institutional Training Initiative (CITI) at www.citiprogram.org. This training is crucial for ensuring that all researchers are equipped with the knowledge to safely handle biological materials, understand regulatory requirements, and mitigate risks associated with biohazards.

Training Certification Submission: Participants must submit copies of their training certification(s) for all personnel listed on the registration forms. CITI training is offered free of charge, allowing users to select and customize modules according to their specific research needs and responsibilities. Certificates of Completion should be submitted via email to ibc.research@umassd.edu.

General concepts covered in CITI biosafety training include:

• Introduction to Biosafety Concepts: Overview of biosafety principles, practices, and the importance of a biosafety culture in research settings.
• Regulations and Guidelines Overview: An introduction to the regulatory framework governing biosafety, including federal, state, and institutional policies.
• OSHA Bloodborne Pathogens Standard: Training on the identification and management of bloodborne pathogens, including exposure prevention and post-exposure procedures.
• Laboratory-Acquired Infections: Insight into the risks of laboratory-acquired infections and the practices necessary to prevent them.
• Risk Management: Strategies for identifying, assessing, and mitigating risks associated with biological materials.
• Select Agents: Overview of select agents and toxins that pose a significant threat to public health and safety.
• Packaging and Shipping: Guidelines for the safe packaging and transport of biohazardous materials, in compliance with federal regulations.
• Animal Biosafety: Best practices for handling animals in research and the associated biosafety considerations.

The following courses are offered via CITI and are required as applicable:

• Biosafety Complete Training: Mandatory for all researchers utilizing biohazardous materials. This training provides comprehensive coverage of safety practices, including risk assessment, personal protective equipment (PPE) usage, and emergency procedures specific to handling biohazards.
• OSHA Bloodborne Pathogens Training: Required for researchers handling human samples. This training ensures participants are knowledgeable about Occupational Safety and Health Administration (OSHA) regulations and the procedures for minimizing exposure risks to bloodborne pathogens.
• Shipping and Transport of Regulated Biological Materials Training: Mandatory for all researchers who need to ship biological samples. This training covers critical regulatory requirements, best practices for packaging, and safety protocols to ensure compliance with federal and state shipping regulations.
• Good Laboratory Practice (GLP): Recommended for all laboratory personnel. This training emphasizes principles that promote quality and consistency in laboratory research, helping ensure reliability and accuracy in experimental results.
• Laboratory Chemical Safety Training: Required for all laboratory personnel using chemicals. This training provides essential information on the safe handling, storage, and disposal of hazardous chemicals, as well as understanding safety data sheets (SDS).
• Radiation Safety Training: Mandatory for all personnel using radioactive materials or devices. This training focuses on safe practices for handling radioactive substances, understanding radiation exposure limits, and emergency response procedures.
• Laser Safety Training: Required for all personnel using lasers. This training covers the safe operation of lasers, the potential hazards associated with laser use, and the necessary protective measures to ensure safety in the laboratory environment.

EHS Laboratory Safety Training

All faculty, staff, graduate students, teaching assistants, and researchers who use chemicals or biological materials (including those with potential bloodborne pathogens), generate hazardous or biohazardous waste, or conduct work beyond classroom activities in laboratories are required to attend EHS Laboratory Safety Training on an annual basis.

Training Content: This comprehensive training provides essential information about:

• EHS Staff and Responsibilities: Understanding the roles of Environmental Health and Safety (EHS) staff in maintaining a safe laboratory environment.
• Right-to-Know Law: Educating participants on their rights regarding hazardous materials in the workplace.
• Emergency Spill Response Notification: Procedures for reporting and managing spills of hazardous substances.
• Bloodborne Pathogens and Biohazards: Information on identifying and managing risks associated with bloodborne pathogens and other biohazardous materials.
• Personal Protective Equipment (PPE): Proper use and selection of PPE to minimize exposure risks.
• Hazardous Waste Management: Guidelines for the safe disposal of hazardous and biohazardous waste in compliance with regulatory requirements.
• Fire Response Procedures: Essential practices for responding to fire emergencies in the laboratory setting.
• Laboratory Practices and Policies: Overview of best practices and institutional policies that govern laboratory work.

Responsibility of Oversight: It is the responsibility of the PI or laboratory manager overseeing the laboratory to ensure all workers have completed the EHS Laboratory Safety Training and are certified. Training certificates are kept on file at the EHS Office.

Training for Students

Students enrolled in courses that include laboratory activities requiring registration with the IBC must complete the necessary training certification via CITI. The faculty member responsible for the course is tasked with monitoring and tracking the training certifications of students enrolled at UMassD.

Immunization Requirements: Faculty should also be aware that all students admitted to UMassD are required to have certain immunizations as mandated by state law, including but not limited to Hepatitis B, which is particularly relevant for students engaged in research involving blood or other potentially infectious materials.

Free Training Resources for Students

Students participating in IBC-regulated research, especially those working with recombinant DNA, biohazards, or infectious agents, are encouraged to complete biosafety training early in their research careers. The following free training resources are available to support their learning:

1. NIH Office of Science Policy (OSP): The NIH provides a wealth of online resources and guidelines for safe research practices involving recombinant or synthetic nucleic acids. Their website features training modules and video tutorials on essential biosafety practices that help students understand the regulatory landscape.

• Link: NIH Office of Science Policy Training

2. Centers for Disease Control and Prevention (CDC) Biosafety Resources: The CDC offers a range of free training materials focused on laboratory biosafety, including comprehensive guides for the safe handling of pathogens and materials. These resources are particularly beneficial for students involved in BSL-1 and BSL-2 level research, ensuring they are aware of safety protocols.

• Link: CDC Safe Labs Biosafety Resources and Tools

3. American Biological Safety Association (ABSA International): ABSA provides numerous free resources, including webinars and online training materials focused on biosafety. Their offerings include videos on risk assessment, lab safety, and best practices for working with biological materials.
   • Link: ABSA Training Tools & Resources

Research-Specific Training

Faculty members are responsible for developing protocols and providing specialized training for staff and students in safe handling practices and procedures for accidental exposure relevant to their specific research activities. This includes:

• Conducting hands-on training sessions.
• Offering guidance on emergency procedures tailored to the specific hazards present in their research.
• Ensuring that all personnel are familiar with the specific risks associated with their research and the best practices for minimizing those risks.